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Evaluation of point of care CD4 Testing in Ethiopia. Belete Tegbaru National HIV Laboratory The Ethiopian Health and Nutrition Research Institute Addis Ababa, Ethiopia. 6 th IAS Conference July 17-20, Rome Italy. Presentation outline. Background Problems & questions Objective

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Evaluation of point of care cd4 testing in ethiopia

Evaluation of point of care CD4 Testing in Ethiopia

Belete Tegbaru

National HIV Laboratory

The Ethiopian Health and Nutrition Research Institute

Addis Ababa, Ethiopia

6th IAS Conference

July 17-20, Rome Italy


Presentation outline
Presentation outline

  • Background

  • Problems & questions

  • Objective

  • Plan of the evaluation

  • Methodology

  • Results

  • Summary

  • Expected Benefits of POC instruments

  • Anticipated Challenges for implementation


As of end of March 2011

In Ethiopia (80 Million Population):

233,361

HIV testing sites

2,309

6,592,896

[+ve, 80,318 (1.2%)]

Total Tested (2010/11)

  • 698

    • 108 Hospitals

    • 590 HCs

Sites giving ART

Sites giving CD4 testing service

  • 138

    • All Hospitals

Currently on ART


Problems questions
Problems & questions

  • Absence of on time CD4 count results (centralized and referred)

Service

  • Distance to sites

  • TAT for results, HIV-DR?

Lost follow-up

  • transport ,storage & power interruption

Cold chain system

Cost

Expertise, maintenance, training, referral linkage


Objective
Objective

To evaluate a point-of-care technology (PIMATM) at different level for CD4 testing sites

  • PimaTM CD4 + T cell Technology - against standard CD4 instruments

  • To see the feasibility: of PIMA for CD4 testing

  • To see how far PimaTMCD4 + T cell Technology could help the facilities to reach their patients on time


Handy & can be charged for those without electricity

Reagent at room temperature

Can be done from finger prick


Plan of the evaluation
Plan of the evaluation

With standard Machines at central &

Hospital lab (N=2 sites, 300 samples)

Phase-I

At Health center level; referred samples (n=7 sites, 750 samples)

+ Finger prick samples (300 samples)

Phase-II

Finger Prick samples

(n=10 sites, 500 samples)

Phase-III


Methodology
Methodology

  • Evaluate against standard machines (FACSCalibur and FACSCount)

  • Intra-test, inter-test, inter-instrument, interpersonal variations were determined

  • Referred samples for FACSCount to referral sites and PIMA on site results were compared

  • Operational parameters (failure rate, rate of additional devices for planning and training were evaluated)


Results
Results

Lab: 27(8.1%, 5.4-11.1)

Site level: 17(10.7%,7.2-18.7] for planning

9.4% extra devices


PIMA versus

FACSCalibur

FACSCount



PIMA versus FACSCount

at health centers before and after referral


PIMA Misclassification rate

Taking 200 cells/µl as a cutoff



Sample

<200: 103 cells/µl

>200: 510 cells/µl

Each test= 10x

Vial-B

Vial-A

Day-1

TECH-B

TECH-A

TECH-A

PIMA-1

PIMA-2

PIMA-1

PIMA-1

Day-2

TECH-A

TECH-A


Sample

Vial-B

Vial-A

Day-1

TECH-B

TECH-A

TECH-A

PIMA-1

PIMA-2

PIMA-1

PIMA-1

Inter machine variation


Sample

Vial-B

Vial-A

Day-1

TECH-B

TECH-A

TECH-A

PIMA-1

PIMA-2

PIMA-1

PIMA-1

Inter technician variation


Sample

Vial-B

Vial-A

Day-1

TECH-B

TECH-A

TECH-A

PIMA-1

PIMA-1

Inter-assay variation


Sample

Vial-B

Vial-A

Day-1

TECH-B

TECH-A

TECH-A

PIMA-1

PIMA-1

Intra-assay variation


Sample

Vial-B

Vial-A

Day-1

TECH-B

TECH-A

TECH-A

PIMA-1

PIMA-2

PIMA-1

PIMA-1

PIMA-1

PIMA-1

Day-2: Daily variation


Meaning of pont of care
Meaning of Pont-of-care

  • In phase-II: 4 HCs tested 255 patients by both PIMA and FACSCount

**- drawing of blood for 2nd time due to lost results

* Reading failure



  • Expansion of sites

  • Reduce the cost of referral

  • Reduce the cost of cold chain

  • Serve the patient on site

  • Reduce lost follow-up

Program

  • Limited training required

  • Storage (room temp. and space)

  • Sample collection (easy and safe)

  • Can be done at lower level

Laboratory

  • Get service on site

  • Initiate ART on time

  • No cost for transport & others

  • Follow their status at any time

  • Increase quality of life

Patient


Anticipated challenges for implementation
Anticipated Challenges for implementation

  • Supply of reagents and machines Vs expansion

    • Mechanism to solve – connectivity and planning

  • Maintenance Vs expansion

    • Preventive maintenance free-

    • Technical service replacement strategy

  • CD4% for pediatric cases

    • development


Summary
Summary

  • Good agreement with standard machines with low bias and good percentage of similarity

  • On Planning: a total of 9.4% extra devices required at lab & site level

  • Failure rate on testing= 8/306= 2.6% at lab level

  • Gives extra advantage – No need to re-draw blood -point-of-care ~5% of the cases

  • Power interruption was not a problem at site level

  • The intra-, inter-tests are within WHO recommendations for ≤200 and >200 cells/l CD4 Tests


Collaborating individuals
Collaborating Individuals

  • Dr. TsehayneshMesele EHNRI

  • Dr. Almaz Abebe EHNRI

  • Mr. Dereje Teshome EHNRI

  • Mr. ErmiasHailu EHNRI

  • Mr. FeyissaChalla EHNRI

  • MrHabteyesHailu EHNRI

  • Mrs. Yodit Alemayehu EHNRI

  • Katherine Theiss-Nyland CHAI

  • Dr. Peter Trevor CHAI


Ethiopian Health and Nutrition Research Institute –Organize and lead the evaluation

CHAI: Financial, material and technical support

Alere: Training of laboratory personnel at the National HIV laboratory


THANK YOU! –Organize and lead the evaluation


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